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Wakix vs Xyrem
Introduction
For patients with narcolepsy, a neurological disorder that affects the control of sleep and wakefulness, Wakix (pitolisant) and Xyrem (sodium oxybate) are two drugs often prescribed. Both medications have shown effectiveness in managing symptoms of excessive daytime sleepiness and cataplexy associated with this condition. However, they work differently within the body.
Wakix is classified as a histamine H3-receptor antagonist/inverse agonist; it enhances wakefulness by increasing histamine levels in the brain. On the other hand, Xyrem works primarily on GABA receptors to increase slow-wave sleep patterns at night which can help reduce daytime symptoms related to narcolepsy. Each medication has unique side effects: Wakix may cause insomnia or nausea while Xyrem can lead to nausea or dizziness but also carries a high risk for abuse due its sedative properties.
Wakix vs Xyrem Side By Side
| Attribute | Wakix | Xyrem |
|---|---|---|
| Brand Name | Wakix | Xyrem |
| Contraindications | Cannot be taken with inhibitors such as rifampicin, phenobarbital, St. John's wort, carbamazepine, or certain antiretroviral drugs. | Cannot be taken with inhibitors such as rifampicin, phenobarbital, St. John's wort, carbamazepine, or certain antiretroviral drugs. |
| Cost | $6,000 to $7,000 for 30 tablets | Around $8,000 for a one-month supply |
| Generic Name | Pitolisant | Sodium oxybate |
| Most Serious Side Effect | Increased suicidal thoughts or self-harm tendencies, severe skin reactions, vision disturbances, cardiovascular symptoms, electrolyte imbalance leading to low sodium levels. | An allergic reaction, changes in mental health, unusual sensitivity reactions like hallucinations and confusion, vision problems, heart issues, bedwetting, and sleepwalking. |
| Severe Drug Interactions | Interactions with inhibitors like rifampicin, phenobarbital, St. John's wort, carbamazepine, or certain antiretroviral drugs. | Interactions with inhibitors like rifampicin, phenobarbital, St. John's wort, carbamazepine, or certain antiretroviral drugs. |
| Typical Dose | Starts at 17.8 mg/day, may be increased to a maximum of 35.6 mg/day after one week. | Begins with a nightly dosage of 4.5 grams, divided into two doses. Can be increased to a maximum of 9 grams per night. |
What is Wakix?
Pitolisant (the generic name for Wakix) is the first drug of its class known as histamine H3 receptor antagonists/inverse agonists, marking a significant step forward in the treatment of narcolepsy. Pitolisant was first approved by the FDA in 2019. It works by increasing histamine levels in the brain, which promotes wakefulness and alertness. Wakix is used for treating excessive daytime sleepiness or sudden muscle weakness in people with narcolepsy.
On the other hand, sodium oxybate (Xyrem) has been available longer since it was approved by the FDA back in 2002. Xyrem primarily enhances slow wave sleep but can also suppress REM sleep where most dreams occur and which seems to be overactive in patients with narcolepsy.
While both drugs are effective at managing symptoms of narcolepsy, they work differently and have different side effects profiles due to their distinct mechanisms of action on neurotransmitters. Wakix specifically increases histamine activity while only subtly influencing dopamine release; this results in fewer side effects compared to medications like Xyrem that strongly affect GABA neurotransmission.
What conditions is Wakix approved to treat?
Wakix is approved for the treatment of certain sleep disorders:
- Narcolepsy, a long-term neurological disorder that involves a decreased ability to regulate sleep-wake cycles.
Xyrem, on the other hand, is approved for:
- Cataplexy in narcolepsy - sudden muscle weakness triggered by strong emotions
- Excessive daytime sleepiness (EDS) in narcolepsy.
How does Wakix help with these illnesses?
Wakix helps to manage the symptoms of narcolepsy by increasing dopamine levels in specific areas of the brain. It works through a mechanism that stimulates histamine neurons, which indirectly leads to an increase in wake-promoting dopamine and norepinephrine neurotransmitters. Dopamine is a chemical messenger that plays vital roles in how we feel pleasure, think and plan. Therefore, by elevating dopamine levels, Wakix can limit excessive daytime sleepiness and cataplexy associated with narcolepsy.
On the other hand, Xyrem treats narcolepsy differently - it has a direct action on GABA receptors which are primarily responsible for inhibitory functions in the nervous system. This dual function allows Xyrem not only to help reduce daytime sleepiness but also to improve disrupted nighttime sleep commonly seen in people with narcolepsy.
What is Xyrem?
Xyrem, known generically as sodium oxybate, is a medication used to treat symptoms of narcolepsy—a chronic sleep disorder characterized by overwhelming daytime drowsiness and sudden attacks of sleep. It specifically targets two key symptoms: excessive daytime sleepiness and cataplexy (sudden loss of muscle control). Xyrem works by influencing the patterns and quality of your sleep, helping you consolidate nighttime sleep which tends to be fragmented in people with narcolepsy. Approved by the FDA in 2002, it's considered unique because it is both a powerful sedative and also capable of increasing alertness during the day.
Importantly, Xyrem does not work on serotonin pathways like many other medications do; instead, its exact mode of action isn't entirely understood but it's thought to exhibit effects through GABA(B) receptors at therapeutic doses. This difference in mechanism means that its side effect profile varies from those drugs working primarily through serotonin modulation—less likely causing issues like weight gain or sexual dysfunction often associated with SSRIs such as Prozac.
The beneficial influence on both wakefulness and cataplexy makes Xyrem particularly advantageous for patients whose narcoleptic condition doesn't respond well to more "typical" treatments or who struggle with significant disruption due to these specific symptoms.
What conditions is Xyrem approved to treat?
Xyrem is a medication that has received approval from the FDA for its use in treating conditions such as:
- Narcolepsy, particularly to improve symptoms of excessive daytime sleepiness and sudden loss of muscle tone (cataplexy)
- Other sleep disorders where there is an irregular or disturbed sleep pattern.
How does Xyrem help with these illnesses?
Gamma-aminobutyric acid (GABA) is a neurotransmitter that inhibits or slows down the brain's functions. This can be beneficial in conditions like narcolepsy, where excessive daytime sleepiness and sudden loss of muscle control can occur due to inappropriate switching between wakefulness and rapid eye movement (REM) sleep. Xyrem works by increasing levels of GABA at GABAB receptors which leads to an increase in slow wave sleep, often deficient in people with narcolepsy. Its unique action on both GABAA and GABAB may also contribute to its efficacy as a treatment for cataplexy, a common symptom of narcolepsy involving sudden muscle weakness triggered by strong emotions. Since it has a different mechanism than typical stimulant medications like modafinil or pitolisant (Wakix), it is sometimes prescribed when patients do not respond well to these treatments or could be combined with them for better management of symptoms.
How effective are both Wakix and Xyrem?
Pitolisant (Wakix) and sodium oxybate (Xyrem) are both approved by the FDA for use in narcolepsy treatment, though they were released to the market nearly two decades apart. Their mechanisms of action differ significantly, with pitolisant working as a selective histamine H3 receptor antagonist/inverse agonist promoting wakefulness, while sodium oxybate primarily acts on GABA B receptors inducing deep sleep that aids daytime alertness.
The effectiveness of pitolisant and sodium oxybate in addressing symptoms of narcolepsy was studied extensively before their approval. In clinical trials, both drugs have been shown to reduce excessive daytime sleepiness and episodes of cataplexy; however, individual patient response can vary significantly. A 2017 study found that patients taking pitolisant experienced an improved Epworth Sleepiness Scale score compared to those given a placebo. The same trial showed minimal adverse reactions related to its use.
A review published in 2004 detailed multiple studies verifying the efficacy of sodium oxybate at reducing symptoms associated with narcolepsy when taken twice nightly as suggested - it notably reduces cataplexy attacks and improves daytime sleepiness scores markedly more than many other medications used for this purpose. Sodium Oxybate has become one of the most commonly prescribed drugs for narcolepsy over time due its profound effect on managing symptoms despite having a relatively strict intake schedule.
A meta-analysis conducted in 2016 indicated that Pitolisant is effective against narcolepsy symptoms compared to placebos but does not show superiority over modafinil or methylphenidate which are other first-line treatments utilized priorly or additionally depending upon patient requirement. Nonetheless, because it operates via different pharmacological pathways from these stimulants as well as Xyrem it may offer alternative options where others fail or cause intolerable side effects like dependence potential seen with traditional stimulants or issues around restrictive access programs required for Xyrem due its abuse potential.
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At what dose is Wakix typically prescribed?
Oral dosages of Wakix start at 17.8 mg/day and then may be increased to a maximum of 35.6 mg/day after one week, based on individual patient response and tolerability. Whereas Xyrem is started at a lower dose, usually between 4.5-9 g/night divided into two doses and over time it can be titrated up to the maximum recommended dosage which is 9 g/night in adults with narcolepsy for the treatment of excessive daytime sleepiness (EDS) and cataplexy. For children, starting dosage depends on weight and age therefore physician's advice should be sought.
At what dose is Xyrem typically prescribed?
Xyrem treatment typically begins with a nightly dosage of 4.5 grams, which is divided into two doses. The first dose should be taken at bedtime and the second dose approximately four hours later. Depending on individual patient response and tolerability, this can then be increased to a maximum of 9 grams per night, again divided into two doses spaced around four hours apart. If there is no significant improvement in symptoms after several weeks or if side effects are troublesome, it may be worth discussing other options with your healthcare provider.
What are the most common side effects for Wakix?
Common side effects of Wakix (pitolisant) include:
- Insomnia
- Nausea
- Anxiety
- Irritability
- Dizziness
- Depression, mood changes and hallucinations in rare cases
While common side effects of Xyrem (sodium oxybate) are more extensive:
- Nausea, vomiting, and diarrhea
- Drowsiness/sleepiness/dizziness
- Bedwetting or increased nighttime urination
- Tremor or shaking
-Anxiety and nervousness
-Sweating
-Decreased appetite -Dry mouth
-Hallucinations or other abnormal thinking
-Bed-wetting
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Are there any potential serious side effects for Wakix?
Like any medication, Wakix has potential side effects that need to be monitored carefully. These include:
- Increased suicidal thoughts or self-harm tendencies
- Signs of allergic reaction which may manifest as hives, difficulty in breathing, swelling on the face or throat
- Other severe skin reactions could also occur: fever, sore throat, burning eyes, and skin pain followed by a red or purple rash that blisters and peels off
- Vision disturbances such as blurred vision or eye pain and swelling; seeing halos around lights is also a possibility
- Cardiovascular symptoms like fast heartbeats that can feel pounding in your chest; shortness of breath coupled with sudden dizziness might make you feel like passing out
- Electrolyte imbalance leading to low sodium levels - this is characterized by headache, confusion slurred speech, pronounced weakness alongside vomiting; loss of coordination making one unsteady are common signs too.
On rare occasions patients reported severe nervous system reactions presenting as very stiff muscles accompanied by high fever and sweating. Confusion ensues along with irregular heartbeats; tremors compound the feeling of passing out.
Anyone experiencing these symptoms should seek immediate medical attention.
What are the most common side effects for Xyrem?
Potential side effects of Xyrem may include:
- Nausea, vomiting and upset stomach
- Bed-wetting or increased urination at night
- Confusion or hallucinations
- Anxiety, depression or mood changes
- Sleepwalking or performing other activities while asleep
- Dizziness, tremors, loss of muscle control (cataplexy)
- Breathing problems during sleep (sleep apnea)
- High blood pressure and fast heartbeat.
It's also important to note that Xyrem can cause significant drowsiness and even periods of complete unconsciousness if the dose is not carefully adjusted by your healthcare provider.
Are there any potential serious side effects for Xyrem?
While Xyrem is commonly used to treat narcolepsy, it's important to be aware of the potential side effects. Some of these might include:
- An allergic reaction: signs could include hives, itching, difficulty breathing, swelling in your face or throat
- Changes in mental health: increased depression or suicidal thoughts are possible; if you notice any unusual changes in mood or behavior consult a healthcare professional immediately
- Unusual sensitivity reactions like hallucinations and confusion
- Vision problems such as blurred vision or seeing halos around lights
- Heart issues including fast or irregular heartbeats
- Bedwetting and sleepwalking can occur due to deep sedation caused by this medication.
If you experience any of the above symptoms while taking Xyrem, contact your doctor right away.
Contraindications for Wakix and Xyrem?
Both Wakix and Xyrem, similar to many other medications for narcolepsy, may lead to worsening of sleep disorders in some individuals. If you notice your symptoms exacerbating or a significant increase in daytime sleepiness and sudden loss of muscle strength (cataplexy), please seek immediate medical attention.
Neither Wakix nor Xyrem can be taken if you are taking or have recently been taking inhibitors such as rifampicin, phenobarbital, St. John's wort, carbamazepine or certain antiretroviral drugs. These substances could interfere with the effectiveness of both Wakix and Xyrem and may require a period of about 2 weeks to clear from the system before starting either medication. Always inform your physician which medications you are currently on; this will help prevent harmful drug interactions.
How much do Wakix and Xyrem cost?
For the brand name versions of these drugs:
- The price of 30 tablets of Wakix (4.45 mg) ranges from $6,000 to $7,000, which works out to about $200–$230/day depending on your dose.
- The price for Xyrem (500mg/mL oral solution) is around $8,000 for a one-month supply that contains two bottles with 180ml each. This can work out to as much as approximately $260-$270 per day.
Thus, if you are in the higher dosage range for Wakix (i.e., 35.6 mg or more), then brand-name Xyrem could be less expensive on a per-day treatment basis but it's very close. As always please note cost should not be your main consideration in determining which drug is right for you.
There are no generic versions available yet for either Wakix (pitolisant) or Xyrem (sodium oxybate). Both medications remain under patent protection and therefore costs remain high until those protections expire and generics enter the market.
Popularity of Wakix and Xyrem
Pitolisant, also known by the brand name Wakix, was approved in 2019 for the treatment of excessive daytime sleepiness (EDS) and cataplexy in adults with narcolepsy. This drug represents a novel approach to managing these key symptoms of narcolepsy as it is the first medication that acts as a histamine H3 receptor antagonist/inverse agonist.
On the other hand, sodium oxybate or Xyrem has been prescribed for many years to treat both EDS and cataplexy in patients with narcolepsy. In 2020, approximately half of all patients diagnosed with narcolepsy were prescribed Xyrem at some point during their treatment course.
It's important to note that while both medications are effective in managing symptoms associated with narcolepsy, they have different modes of action and side effect profiles which may influence choice of therapy depending on individual patient characteristics. For instance, unlike Xyrem which is often linked with central nervous system depression effects like sedation or respiratory compromise especially when combined with other CNS depressants; Wakix through its unique mechanism does not carry a risk for physical dependence nor does it require titration upon initiation making it potentially more suitable option for certain individuals.
Conclusion
Both Wakix (pitolisant) and Xyrem (sodium oxybate) are approved for the treatment of narcolepsy, a neurological disorder characterized by excessive daytime sleepiness and sudden episodes of muscle weakness. Both have been shown in clinical studies to be more effective than placebo treatments. They may sometimes be used together under careful guidance by a physician as they have different mechanisms of action; Wakix works primarily on histamine receptors promoting wakefulness while Xyrem decreases the number of awakenings during the night due to its influence on GABA neurotransmitter system.
Presently, both medications do not exist in generic forms which can mean high costs for patients paying out-of-pocket. There might also be an adjustment period with both drugs where effects aren't noticeable immediately.
Side effect profiles between these two drugs vary significantly: common side effects with Wakix include insomnia, nausea, and anxiety while those with Xyrem consist mainly of nausea, dizziness, bedwetting and depression. For both medications, patients must closely monitor their symptoms especially when initiating or modifying therapy and should seek medical help if serious side effects occur such as hallucinations in case of Wakix or respiratory problems in case of Xyrem.
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Refrences
- Syed, Y. Y. (2016, July 20). Pitolisant: First Global Approval. Drugs. Springer Science and Business Media LLC.http://doi.org/10.1007/s40265-016-0620-1
- Lee, E., & Douglass, A. (2015, July). Baclofen for narcolepsy with cataplexy: two cases. Nature and Science of Sleep. Informa UK Limited.http://doi.org/10.2147/nss.s86649
- Lamb, Y. N. (2020, January 29). Pitolisant: A Review in Narcolepsy with or without Cataplexy. CNS Drugs. Springer Science and Business Media LLC.http://doi.org/10.1007/s40263-020-00703-x